What Determines a Positive Outcome of Spinal Manipulation for Persistent Low Back Pain: Stiffness or Pain Sensitivity? A Randomized Trial
CompletedNot applicableNCT04086667
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
Introduction Several treatment methods have been proposed to ease the burden of low back pain (LBP) but none are clearly superior. Spinal manipulative therapy (SMT) is a guideline recommended treatment, but the effect is moderate to low. Previous publications suggest that acute LBP patients with who are more stiff are more likely to improve with SMT. However, as LBP persists changes in the central nervous system which modulates the pain experience becomes hypersensitive and possible stiffness is not as important an factor. Experimentally SMT may have a reversible effect of this sensitization. Objective The primary objective of this study is, to examine whether SMT is more effective in regards to short term pain relief when directed at level in the lower back characterized by spinal stiffness or pain hypersensitivity in persistent LBP. Methods A double blinded randomized clinical trial of up to 155 participants with persistent LBP included at a multidisciplinary Spinecenter. spinal stiffness (Global Stiffness Score) is measured using the VerteTracker, a novel device that can quantify stiffness. Pain sensitivity is measured as pain threshold, tolerance, temporal summation (TS) and conditioned pain modulation(CPM). Participants receive SMT at either "the stiffest" or "the most sensitive" segment, a total of four times over a 14-day period. The quantitative measures are recorded at baseline, post treatment and at 4-weeks follow-up along with a numerical pain rating (NRS) and the a disability index (ODI). Discussion These novel findings could improve clinical decision rules - specifically at which level in the lower back to direct SMT. Furthermore, the results will potentially shed light on the underlying mechanisms of SMT - are treatment effects mediated primarily by changes in stiffness or central hypersensitivity?
Study details
- Official title
- What Determines a Positive Outcome of Spinal Manipulation for Persistent Low Back Pain: Stiffness or Pain Sensitivity? A Randomized Trial
- Conditions
- Interventions
- Sponsor
- Spine Centre of Southern Denmark
- Collaborators
- Berit Schiøttz-Christensen; Søren O'Neill; Gregory Kawchuk
- Start date
- 2017-11-01
- Primary completion
- 2019-02-01
- Sex
- All
- Age range
- from 18 Years to 60 Years
- Results posted
- No results posted in this snapshot
- Countries
- Denmark
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: To be enrolled in the study, the participant must fulfill the following: * Informed written consent * Have the ability to speak and read Danish. * Between the age of 18 and 60. * Body mass index \< 35 * LBP \> 3 months, defined as pain on the posterior aspect of the body between the 12th thoracic vertebrae and the gluteal folds. * No previous back surgery and must not have had surgery in general in the last 4 months. * Must not have received spinal manipulation in the last month. * Must not take other pain medication than paracetamol, NSAIDs or weak synthetic opioids * Not have radiculopathy: dermatomal leg pain and a positive straight-leg-raise test \<60 degrees. * Not have problems regarding deep vein thrombosis, circulatory issues in the under extremity, compartment syndrome or severe lung diseases * No competing diagnoses which could a) confound the diagnosis of NSLBP e.g. osteoporosis, cancer, fibromyalgia etc. b) interfere with the allocated treatment or c) interfere with QST and VT testing Exclusion Criteria: Participants will be excluded during the study if: * Not completing the allocated intervention (minimum 75% of scheduled treatments). * Receiving other treatment than that administered as part of the study * Deviate from the agreed upon medication at baseline measures within the treatment period. * Inability to hold breath for 10 seconds
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04086667